Clinical Protocol definition

Clinical Protocol means the document that specifies the testing procedures and conditions for clinical studies in accordance with applicable regulatory requirements in the form of Attachment A to the applicable Project Agreement.
Clinical Protocol means protocol no. [***], as well as amendments that relate to the Gap Period and the Follow Up Period (each as defined below), together with all other amendments thereto, approved by the relevant French regulatory authorities.
Clinical Protocol means a document outlining human subjects studies requiring IRB approval. Clinical protocols may include clinical trials1, non-interventional observational (natural history) studies, screening protocols, and repository protocols. The scientific review process includes the initial protocol review, annual and quadrennial review of the ongoing protocol, and review of substantive modifications to the protocol that pose new scientific questions or substantially alter the scientific approach. In addition, the scientific review process includes prioritization of clinical protocols utilizing scarce resources at the NIH Clinical Center (CC) to assure the best science is being supported. These reviews become part of the official protocol record and are made available to the IRB and NIH leadership.

Examples of Clinical Protocol in a sentence

  • INSERM represents and warrants that INSERM and the Investigator will conduct the INSERM Trial in accordance with (a) Applicable Law, (b) the Clinical Protocol, and (c) the terms of this Amendment No 2.

  • For the avoidance of doubt, the Clinical Protocol Compliance will not cover any new clinical trials, or new patients.

  • The Clinical Protocol is attached to this Agreement as Attachment A.

  • Hospital and Principal Surgeon shall not allow the Surgery nor any preparation for the Surgery until the IRB has unconditionally approved all the terms and conditions of the Surgery, including without limitation the Informed Consent of the Patient, the Clinical Protocol and the participation of Hospital and Principal Surgeon in the Surgery.

  • Where applicable, Parent shall provide in any Disposition Agreement that any purchaser of a CVR Product with Clinical Protocol Compliance obligations shall maintain and observe such Clinical Protocol Compliance.

  • In providing the Services, ARC will use reasonable efforts to collect source leukocytes and plasma (“Blood Related Material” or “BRM”) from eligible volunteer donors according to the Clinical Protocol).

  • The Access Policy Work Group shall work in cooperation with the Program Manager and/or Access Coordinator (or Coordinating Committee), ▇▇▇▇▇▇’▇ Clinical Protocol Work Group and ▇▇▇▇▇▇’▇ Education & Training Work Group and any relevant third-party consultants retained by Kaiser.

  • Execution Copy While the GMP production protocol is being developed, Telethon-OSR will continue to pursue exploratory studies in order to ensure rapid implementation of the GMP Clinical Protocol.

  • Applications that lack the Complete Clinical Protocol are incomplete and will not be reviewed.

  • The Access Policy Work Group shall work in cooperation with the Program Manager and/or Access Coordinator (or Coordinating Committee), ▇▇▇▇▇▇'▇ Clinical Protocol Work Group and ▇▇▇▇▇▇'▇ Education & Training Work Group and any relevant third-party consultants retained by Kaiser.


More Definitions of Clinical Protocol

Clinical Protocol means the specific clinical trial protocol as part of the Project;
Clinical Protocol means a protocol for the conduct of Research agreed in writing between the parties
Clinical Protocol means the content and timing of interactions with Clinical Users and Registered Patients via the Platform, including information, instructions, assessments and messages sent to Clinical Users and Registered Patients, and (where applicable) monitored by Clinical Team Members relating to a patient’s preparation for and recovery from their treatment;
Clinical Protocol means the document outlining human subjects research that involves engagement with the subject and for this purpose requires IRB approval. Clinical protocols may include clinical trials1, non-interventional natural history studies, screening protocols, and teaching and training protocols.

Related to Clinical Protocol

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Step therapy protocol means a protocol or program that establishes the specific

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Kyoto Protocol Means the protocol to the UNFCCC adopted at the third conference of the parties to the UNFCCC in Kyoto, Japan, on December 11, 1997.

  • Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;